Controversial scientist He Jiankui was condemned by academics who say his work on editing the genes of unborn twin girls was unnecessary, precarious and presented unnecessary risks to babies.
Researchers Haoyi Wang and Hui Yang, both well-known in the field of gene-editing, have written an opinion piece in the respected scientific journal Plos One, dismantling the science behind their work.
They say that their procedure was not only morally reprehensible and far beyond the scope of any ethical consideration, but also that their scientific method was negligent and unnecessary.
They claim in the play that "early genetic-editing embryos do not provide benefits for babies, while posing potentially serious risks on several fronts."
The disgraced researcher used CRISPR-Cas9 gene-editing technology to alter the embryonic genes of twin girls dubbed "Lulu" and "Nana."
He said the rationale for the experiment was to confer immunity to HIV to the embryos to avoid infection of the father, who is HIV positive.
He has already been fired from his university post and is being investigated by Chinese authorities.
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He Jiankui speaks during an interview at a laboratory in Shenzhen, Guangdong Province, southern China. The Chinese scientist claims that he helped create the world's first genetically modified babies: twin girls whose DNA he claims changed
Experts argue that Dr. He's work was fundamentally ill-conceived – starting with the fact that under the circumstances, genetic editing was totally unnecessary.
Dr. Wang and Dr. Yang stated that the infection could have been avoided during conception using well-established assisted reproduction technologies.
Likewise, the infection could have been avoided after birth simply by avoiding any potential risk of exposure to HIV.
This, they note, "is enough for most people."
The gene that dr. He edited himself is called CCR5 and is involved in regulating the body's immune system.
Although naturally occurring mutations in CCR5 have been associated with higher levels of resistance to infection, specifically in European populations, they do not block all strains of HIV.
He has tried to deactivate a gene called CCR5 that forms a protein gateway that allows HIV, the virus that causes AIDS, to enter a cell.
All men in the project had HIV and all women did not, but the genetic editing was not aimed at avoiding the small risk of transmission, Dr. He said.
He also did not submit a long-term plan to monitor the two children in order to assess the impact of the procedure, they say.
The conduct of Dr. He and his colleagues, conclude the researchers, "represents a gross violation of Chinese regulations and the consensus reached by the international scientific community."
"We strongly condemn their actions as extremely irresponsible, both scientifically and ethically," they added.
The scientist provoked global controversy in November when he announced in a video on YouTube what he had done.
The scientific world and the general public were surprised when Dr. He Jiankui released his video on YouTube, claiming to have created human twins edited with genes.
Scholars condemned their unethical actions and criticized their procedure, intentions, and extravagant approach to morality.
The government has suspended work in its laboratory and is conducting an investigation, saying it would require a "zero tolerance attitude to deal with dishonorable behavior" in the research.
Between March 2017 and November 2018, he forged ethical review articles and recruited eight couples to participate in his experiment, resulting in two pregnancies.
This graph reveals how, theoretically, an embryo could be "edited" using the powerful Crispr-Cas9 tool to defend humans against HIV infection.
Five others did not result in fertilization, while one chose to leave the experiment.
He is believed to be under constant surveillance by armed guards after death threats and imminent lawsuits.
The punishment for his actions would probably be severe and some speculated that this could result in the death penalty.
William Nee, an Amnesty International researcher in China, said: "China runs more people than any other country in the world, and the country's death penalty system is shrouded in secrecy.
Suspects often do not have access to lawyers during the main stages of the legal process and the use of torture to extract forced confessions is plentiful.
"In highly politicized cases, judgment is often a mere spectacle with the result already decided."
The South University of Science and Technology (SUSTech) in Shenzhen said in a statement on its website that it was fired.
HOW DO DR DESCRIBE THE WORK?
"Gene editing occurred during in vitro fertilization, or in laboratory fertilization.
First, the sperm was & # 39; washed to separate it from the semen, the fluid where HIV can hide.
A single sperm was placed in a single egg to create an embryo.
Then the gene editing tool was added.
When the embryos were three to five days old, some cells were removed and checked for editing.
Couples can choose to use either published or unedited embryos for attempted pregnancies.
"In all, 16 of the 22 embryos were edited, and 11 embryos were used in six attempts to implant before the twin pregnancy was achieved."
"With immediate effect, SUSTech will terminate the employment agreement with Dr. Jiankui He and will terminate any of its teaching and research activities at SUSTech," the statement said, adding that the decision came after a preliminary investigation by the Task Force of Guangdong Province Research.
Dr. He was trained as a physicist, not as a biologist, and therefore was not qualified and probably unable to perform the research alone.
He is believed to have used his own £ 40 million fortune to fund the project and privately recruited highly trained scientific professionals to conduct the research.
Little is known about the research that baffled scientists by blatantly displaying all the rules and guidelines on ethics and legality in genetics.
The whereabouts of the Chinese researcher has been a mystery since November. The reports alleged that he was placed under effective house arrest in Shenzhen after making an appearance at the Second International Summit on the Human Genome Edition in Hong Kong at the end of November.
He and his family are living in housing at universities at the Southern University of Science and Technology in Shenzhen, with guards parked outside their apartment, according to a recent Bloomberg report citing Dr. William Hurlbut, associate professor at Stanford Medical School . in contact with the Chinese scientist.
"He told me that both in his life situation and in the investigation process he is being treated respectfully," said Hurlbut, a neurobiologist Dr. He had consulted in the past two years in his genetic research, told reporters.
The two children, LuLu and Nana, were born in October, it is believed, and the potentially dangerous changes made in their genome can then be passed on to future generations, a field of research still incipient and largely unknown.
It is a controversial work, which earned him the nickname "Chinese Frankenstein", was condemned by the medical community and Chinese health authorities, who said they did not know anything about the experiment.
The editing of genes is banned in Britain, the USA, in many other parts of the world, and researchers have said that if Dr. He's statements are true, the "monstrous" experiment was not "morally or ethically defensible" .
There is no independent confirmation of Dr. He's claim, and it was not published in a journal where it would be examined by other experts.
It's inconceivable … an experiment in humans that is not morally or ethically defensible, "said Dr. Kiran Musunuru, a gene-editing expert at the University of Pennsylvania and editor of a genetics journal.
"This is too premature," said Dr. Eric Topol, who heads the Scripps Research Translational Institute in California. We are dealing with the operating instructions of a human being. It's a great deal. "
"If this is true, this experience is monstrous," said Professor Julian Savulescu, director of the Uehiro Center for Practical Ethics at the University of Oxford.
These healthy babies are being used as genetic guinea pigs. This is genetic of the Russian Roulette.
In recent years, scientists have discovered a relatively easy way to edit genes, the DNA strands that govern the body.
WHAT ARE SOME OF THE DOUBTS IN THE INVOLVEMENT OF DR HE CLAIMS?
Several scientists analyzed materials that Dr. He provided to the AP and said the tests so far are insufficient to say that the edition worked or to rule out the damage.
They also noticed evidence that the issue was incomplete and that at least one of the twins appears to be a patchwork of cells with several changes.
"It's almost like not editing anything," if only a few cells have been altered because HIV infection can still occur, said Professor George Church, a famous geneticist at Harvard University.
Church and Dr. Kiran Musunuru, a gene-editing specialist at the University of Pennsylvania, questioned the decision to allow one of the embryos to be used in an attempted pregnancy because Chinese researchers said they knew in advance that both copies of the gene had not been changed.
"In that child, there was almost nothing to be gained in terms of protection against HIV and yet you are exposing this child to all the unknown security risks," Musunuru said.
The use of this embryo suggests that the main emphasis of the researchers was on editing tests, rather than avoiding this disease, Church said.
Even though the issue worked perfectly, people with no CCR5 normal genes face greater risks of contracting certain viruses, such as the West Nile, and dying of the flu.
As there are many ways to prevent HIV infection and it is very treatable if it occurs, these other medical risks are a concern, Musunuru said.
There are also questions about how Dr. He said he proceeded.
He gave official news of his work long after he said he started – on November 8 in a Chinese registry of clinical trials.
It is unclear whether participants fully understood the purpose and the potential risks and benefits.
For example, consent forms called the AIDS vaccine development project.
The hospital linked to the controversial bill denied approval of the procedure and accused Dr He of forgery.
The tool, called CRISPR-cas9, makes it possible to operate on DNA to provide a needed gene or to disable one that is causing problems.
It has only recently been attempted in adults to treat deadly diseases, with all issues confined to that person, which means that they can not be passed on to the children.
Sperm, ovule, or embryo editing is different – changes can be inherited.
In the US, it is not allowed except for laboratory research. China prohibits human cloning, but not specifically gene editing.
The Doctor. He Jiankui, who studies "JK", studied at the Rice and Stanford universities in the US before returning to his homeland to open a laboratory at the China University of Science and Technology in Shenzhen, where he also has two genetics companies.
He said he chose to test the editing of embryo genes for HIV because those infections are a big problem in China.
Parents have had their infections profoundly suppressed by standard HIV medications and there are simple ways to prevent them from infecting offspring that do not involve altering genes.
Instead, the call was to offer HIV-affected couples a chance to have a child who could be protected from a similar fate.
He recruited couples through an AIDS advocacy group called Baihualin.
Full comments by Haoyi Wang and Hui Yang were published in the journal PLOS Biology.
WHAT IS CRISPR-CAS9?
CRISPR-Cas9 is a tool for making precise editions of DNA, discovered in bacteria.
The acronym stands for "Clustering Regularly Interchained Palindromic Repetitions".
The technique involves a DNA cutting enzyme and a small label that tells the enzyme where to cut.
The CRISPR / Cas9 technique uses tags that identify the location of the mutation and an enzyme, which acts as a small scissors, to cut the DNA in a precise location, allowing small portions of a gene to be removed.
By editing this tag, scientists can direct the enzyme to specific regions of the DNA and make precise cuts, wherever they want.
It has been used to & quot; silence & quot; genes – effectively shutting them down.
When the cellular machinery fixes the breaking of the DNA, it removes a small fragment of DNA.
In this way, researchers can precisely deactivate specific genes in the genome.
The approach was previously used to edit the HBB gene responsible for a condition called β-thalassemia.